艾哈迈德·巴伐尔特（Ahmed Baerveldt）比较研究的 1 年随访后治疗结果。
Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up.
机构信息
Department of Ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, FL 33136, USA.
出版信息
Ophthalmology. 2011 Mar;118(3):443-52. doi: 10.1016/j.ophtha.2010.07.016. Epub 2010 Oct 8.
PURPOSE
To determine the relative efficacy and complications of the Ahmed glaucoma valve (AGV) model FP7 (New World Medical, Ranchos Cucamonga, CA) and the Baerveldt glaucoma implant (BGI) model 101-350 (Abbott Medical Optics, Abbott Park, IL) in refractory glaucoma.
DESIGN
Multicenter, randomized, controlled clinical trial.
PARTICIPANTS
Two hundred seventy-six patients, including 143 in the AGV group and 133 in the BGI group.
METHODS
Patients 18 to 85 years of age with refractory glaucoma having intraocular pressure (IOP) of 18 mmHg or more in whom an aqueous shunt was planned were randomized to undergo implantation of either an AGV or a BGI.
MAIN OUTCOME MEASURES
The primary outcome was failure, defined as IOP >21 mmHg or not reduced by 20% from baseline, IOP ≤5 mmHg, reoperation for glaucoma or removal of implant, or loss of light perception vision. Secondary outcomes included mean IOP, visual acuity, use of supplemental medical therapy, and complications.
RESULTS
Preoperative IOP (mean±standard deviation [SD]) was 31.2±11.2 mmHg in the AGV group and 31.8±12.5 mmHg in the BGI group (P = 0.71). At 1 year, mean±SD IOP was 15.4±5.5 mmHg in the AGV group and 13.2±6.8 mmHg in the BGI group (P = 0.007). The mean±SD number of glaucoma medications was 1.8±1.3 in the AGV group and 1.5±1.4 in the BGI group (P = 0.071). The cumulative probability of failure was 16.4% (standard error [SE], 3.1%) in the AGV group and 14.0% (SE, 3.1%) in the BGI group at 1 year (P = 0.52). More patients experienced early postoperative complications in the BGI group (n = 77; 58%) compared with the AGV group (n = 61; 43%; P = 0.016). Serious postoperative complications associated with reoperation, vision loss of ≥2 Snellen lines, or both occurred in 29 patients (20%) in the AGV group and in 45 patients (34%) in the BGI group (P = 0.014).
CONCLUSIONS
Although the average IOP after 1 year was slightly higher in patients who received an AGV, there were fewer early and serious postoperative complications associated with the use of the AGV than the BGI.
目的
确定 Ahmed 青光眼引流阀（AGV）模型 FP7（新视界医疗，兰乔库卡蒙加，加利福尼亚州）和 Baerveldt 青光眼植入物（BGI）模型 101-350（雅培医疗光学，雅培公园，伊利诺伊州）在难治性青光眼中的相对疗效和并发症。
设计
多中心、随机、对照临床试验。
参与者
276 名患者，其中 AGV 组 143 名，BGI 组 133 名。
方法
年龄在 18 至 85 岁之间的难治性青光眼患者，眼压（IOP）为 18mmHg 或更高，计划行房水分流术，随机接受 AGV 或 BGI 植入。
主要观察指标
主要结局为失败，定义为 IOP>21mmHg 或与基线相比降低<20%，IOP≤5mmHg，青光眼再次手术或植入物取出，或光感丧失。次要结局包括平均 IOP、视力、辅助药物治疗的使用和并发症。
结果
AGV 组术前 IOP（均值±标准差[SD]）为 31.2±11.2mmHg，BGI 组为 31.8±12.5mmHg（P=0.71）。1 年后，AGV 组平均 IOP±SD 为 15.4±5.5mmHg，BGI 组为 13.2±6.8mmHg（P=0.007）。AGV 组平均 IOP±SD 为 1.8±1.3，BGI 组为 1.5±1.4（P=0.071）。AGV 组 1 年累积失败概率为 16.4%（标准误差[SE]，3.1%），BGI 组为 14.0%（SE，3.1%）（P=0.52）。与 AGV 组（61 例，43%）相比，BGI 组（77 例，58%）患者术后早期并发症更多（P=0.016）。AGV 组 29 例（20%）和 BGI 组 45 例（34%）患者发生与再次手术、视力丧失≥2 个 Snellen 线或两者均相关的严重术后并发症（P=0.014）。
结论
尽管接受 AGV 治疗的患者平均术后 1 年的眼压略高，但与 BGI 相比，AGV 的术后早期和严重并发症较少。
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